藏悠游胶囊安全性毒理学评价及提高缺氧耐受力功能研究  

Assessment on Toxicological Safety and Anoxia Endurance Improving Function of Zangyouyou Capsules

作　　者：张娟 李水仙 王春芳 赵岩 祝清芬 ZHANG Juan;LI Shui-xian;WANG Chun-fang;ZHAO Yan;ZHU Qing-fen(Shandong Institute of Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,山东济南250101

出　　处：《食品与药品》2020年第2期94-102,共9页Food and Drug

摘　　要：目的评价保健食品藏悠游胶囊的食用安全性和提高缺氧耐受力的功能。方法采用最大耐受剂量(MTD)法进行小鼠急性毒性试验;通过Ames试验、骨髓细胞微核试验和小鼠睾丸染色体畸变试验评价其遗传毒性;采用大鼠30 d喂养试验评价其亚急性毒性;小鼠连续灌胃30 d 0.27,0.54,1.62 g/kg BW(分别相当于人体推荐用量的5,10,30倍)藏悠游胶囊,检测其对常压耐缺氧存活时间、亚硝酸钠中毒存活时间、急性缺血性缺氧喘气时间的影响。结果受试物小鼠经口MTD>20 g/kg BW;5000,1000,200,40,8μg/皿剂量组Ames试验阴性;2.5,5,10 g/kg BW剂量组小鼠骨髓细胞微核试验和小鼠精子畸形试验结果均为阴性;1.35,2.7,5.4 g/kg BW剂量喂养30 d未见明显与受试物相关的异常改变;0.27,0.54,1.62 g/kg BW剂量组均能延长常压耐缺氧存活时间和急性缺血性缺氧喘气时间,0.54 g/kg BW剂量组能延长亚硝酸钠中毒存活时间。结论藏悠游胶囊具有较高的食用安全性,且具有提高缺氧耐受力的功能。Objective To evaluate the edible safety and anoxia endurance improving function of Zangyouyou Capsules.Methods Acute toxicity test of Zangyouyou Capsules was assessed by determination of the maximal tolerated dose(MTD).Genetic toxicity was evaluated by Ames test,bone marrow micronucleus test and mouse sperm abnormality test.The subacute toxicity was assessed by a 30 d feeding test in rats.The mice of experimental groups were given orally Zangyouyou Capsules for 30 days at the dosages of 0.27,0.54 and 1.62 g/kg BW(equivalent to 5,10 and 30 times of the recommended amount for human body)respectively,and the effects of Zangyouyou Capsules on the survival time of mice under hypoxia at atmospheric pressure,the survival time of mice subjected to NaNO2 and mouth breathing time after acute lack of blood in brain were detected.Results The MTD for oral administration was greater than 20 g/kg BW.The results of Ames test were negative at the dose of 5000,1000,200,40 and 8μg/dish.The results of the mouse bone marrow cell micronucleus test and mouse sperm abnormality test at the dose of 2.5,5 and 10 g/kg BW were all negative.There were no obvious abnormal changes related to the subjects in 30 d feeding test at the dose of 1.35,2.7 and 5.4 g/kg BW.Zangyouyou Capsules at the dose of 0.27,0.54 and 1.62 g/kg BW all extended survival time of mice under hypoxia at atmospheric pressure and mouth breathing time after acute lack of blood in brain,while 0.54 g/kg BW of Zangyouyou Capsules prolonged the survival time of mice subjected to NaNO2.Conclusion Zangyouyou Capsules show high edible safety and can improve anoxia endurance of mice.

关 键 词：藏悠游胶囊 急性毒性 遗传毒性 缺氧耐受力 

分 类 号：TS218[轻工技术与工程—粮食、油脂及植物蛋白工程]